Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
O4 Global Trading Usa, Llc
ORAL
OTC DRUG
Pain reliever Nighttime sleep aid - temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
OTC monograph not final
ONLY FOR BODY PAIN- ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET O4 GLOBAL TRADING USA, LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- _ONLY FOR_ - BODY PAIN _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH CAPLET)_ Acetaminophen 500 mg Diphenhydramine HCl 25 mg _PURPOSE_ Pain reliever Nighttime sleep aid _USES:_ temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness _WARNINGS:_ LIVER WARNING: This product contains acetaminophen. Severe liver damage may occur if you take: more than 1,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. DO NOT USE with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had any allergic reaction to this product or any of its ingredients for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor ASK A DOCTOR BEFORE USE IF YOU HAVE • liver disease • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma ASK A DOCTOR BEFORE USE IF YOU ARE • taking the blood thinning drug warfarin • taking sedatives or tranquilizers WHEN USING THIS PRODUCT • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery STOP USE AND ASK A DOCTOR IF • sleeplessness persists continously for more than 2 weeks. In Lesen Sie das vollständige Dokument